New Options for Avoiding a Dedicated TQT Study – The Impact of the New ICH E14/S7B Revisions Webinar Replay
In this webinar replay, we discuss the impact of the new ICH E14 and S7B revisions on the cardiac safety assessment of new compounds. Dr. Darpo discusses the new E14 material and the practical implications for taking advantage of the new pathways potentially available for drug developers. Dr. Kleiman discusses the changes to S7B from the view of a clinician, with an emphasis on how drug developers on the clinical side will need to review in vitro and in vivo CV safety data. They then share their impressions on the new opportunities that these revisions provide for drug development, as well as some thoughts on the as yet unresolved issues that will only become clarified over the next few years as regulators become more familiar with nonclinical data.
Watch this webinar replay to understand the recent changes to ICH E14 & S7B revisions.